EFAI ChestSuite XR Pleural Effusion Assessment System

Ever Fortune.AI Co., Ltd.
EFAI ChestSuite XR Pleural Effusion Assessment System Model Card
Product Details
Model Identifier
Manufacturer
Ever Fortune.AI Co., Ltd.
Product
EFAI ChestSuite XR Pleural Effusion Assessment System
Version
Unknown
Date Cleared
11/08/2022
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
Adult Chest Xray
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
EFAI PNXXR is a software workflow tool designed to aid the clinical assessment of adult (22 years of age or older). Posteroanterior (PA) view Chest X-Ray cases with features suggestive of pneumothorax in the medical care environment. EFAI PNXXR analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. EFAI PNXXR is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pneumothorax or otherwise preclude clinical assessment of X-Ray cases.
Intended User
Clinicians
Age
Adult
Anatomy
Chest
Modality
XRAY
Output
Notify PACS/workstation for the presence of Pneumothorax
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
Unknown
Age Range (Years)
Unknown
Sex (%)
  • Female: Unknown
  • Male: Unknown
  • Unknown: Unknown
Output
Unknown
Race (%)
  • White: Unknown
  • Black or African American: Unknown
  • American Indian or Alaska Native: Unknown
  • Asian: Unknown
  • Native Hawaiian or Other Pacific Islander: Unknown
  • Unknown: Unknown
Ethnicity (%)
  • Hispanic or Latino: Unknown
  • Not Hispanic or Latino: Unknown
  • Unknown: Unknown
Geographic Region (%)
  • USA: Unknown
  • International: Unknown
  • Unknown: Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
Model Performance
Study Type
Performance Testing Type
Stand-Alone Performance
Standalone Model Performance
Reference Standard (Ground Truth)
Interpretation by Reviewing Clinician
No. of Cases
800
Age Range (Years)
Unknown
Sex (%)
Female: 43
Male: 56
Race (%)
  • White: Unknown
  • Black or African American: Unknown
  • American Indian or Alaska Native: Unknown
  • Asian: Unknown
  • Native Hawaiian or Other Pacific Islander: Unknown
  • Unknown: Unknown
Ethnicity (%)
  • Hispanic or Latino: Unknown
  • Not Hispanic or Latino: Unknown
  • Unknown: Unknown
Geographic Region (%)
  • USA: Unknown
  • International: Unknown
  • Unknown: Unknown
Output
Positive: 23% Negative: 77%
Scanner Manufacturer(s)
Canon\Toshiba;Fujifilm;GE;Philips;Samsung;Konica Minolta;Shimadzu;Swissray
Scanner Model(s)
Unknown
No. of Sites
3
Model Accuracy
99% (95% CI=0
Model Sensitivity
97% (95% CI: 94%, 99%)
Model Specificity
98% (95% CI: 96%, 99%)
Reader Study Performance
No. of Readers
N/A
No. of Cases
N/A
No. of Sites
N/A
Output
N/A
Age Range (Years)
N/A
Sex (%)
  • Female: N/A
  • Male: N/A
  • Unknown: N/A
Race (%)
  • White: N/A
  • Black or African American: N/A
  • American Indian or Alaska Native: N/A
  • Asian: N/A
  • Native Hawaiian or Other Pacific Islander: N/A
  • Unknown: N/A
Ethnicity (%)
  • Hispanic or Latino: N/A
  • Not Hispanic or Latino: N/A
  • Unknown: N/A
Geographic Region (%)
  • USA: N/A
  • International: N/A
  • Unknown: N/A
Scanner Manufacturer(s)
N/A
Scanner Model(s)
N/A
Model Accuracy
N/A
Model Sensitivity
N/A
Model Specificity
N/A
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
All
Slice Thickness
Unknown
Contrast Use
Unknown
MRI Field Strength
Unknown
Reconstruction Kernel Used
Unknown
Alternative Choices
Alternative Choices
Previous Version(s)
Unknown
Contact Information
Contact Information
Point of Contact Name
Unknown
Email
Unknown
Additional Details
Related Use Cases
Unknown
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